Mass Tort Update- |
- Philadelphia, PA 215-567-3500
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- Red Bank, NJ 732-747-9003
Mass Tort Update
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Primary Efficacy Results:
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Efficacy
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Baseline
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EOS(after 6 months)
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HbA1c in %: median, mean (SD)
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8.2, 8.5 (1.47)
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6.9, 7.1 (1.20)
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HbA1c Response Rate (reduction >0.7%), n (%)
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-
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14,364 (72.0)
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Secondary Outcome Variables (Efficacy Evaluable Population):
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FBG (mg/dl): median, mean (SD)
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179, 188 (53.1)
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129, 137 (40.0)
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FBG Response Rate (Reduction >30mg/dl), n (%)
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-
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13,496 (67.6)
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Systolic BP: median, mean (SD)
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140, 144 (16)
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140, 138 (13)
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Diastolic BP: median, mean (SD)
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85, 84 (9)
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80, 82 (7)
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Body Weight: median, mean (SD)
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83.75, 84.9 (15.47)
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82.0, 83.9 (14.97)
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Antidiabetic Therapy During the Course of the Study
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n (%)
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RSG + Metformin
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7,160 (36)
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RSG + Sulfonylurea
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5,033 (25)
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RSG Triple Therapy
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4,247 (21)
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RSG Monotherapy
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1,017 (5)
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RSG + Other Oral Combinations
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224 (1)
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RSG + =3 Oral Combinations
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397 (2)
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RSG + Insulin
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56 (<1)
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Switch or Unclear
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1,828 (9)
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Safety Results all observed subjects were included in the safety evaluation
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Total
N=22,808
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Subjects with any AE(s), n(%)
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705 (3)
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Most Frequent Adverse Events On Therapy (from report, Oct 2002)
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n (%)
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Weight Increase
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116 (0.51)
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Nausea
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85 (0.37)
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Abdominal Pain
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54 (0.24)
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Dizziness
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39 (0.17)
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Edema Legs
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38 (0.17)
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Diarrhea
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37 (0.16)
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Edema
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31 (0.14)
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Headache
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28 (0.12)
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Tolerance Decreased
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26 (0.11)
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Bronchitis
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24 (0.11)
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Flatulence
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24 (0.11)
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